To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study

Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women

A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women

A double blind study of a new type of vitamin D ,named doxercalciferol ( 1α hydroxyvitamin D2) or placebo is given to study its effect on preventing and treating osteoporosis.The trial was a pilot study for one year that was extended to a second year . We used Dual energy Xray absorptiometry (DEXA) to measure bone density of the spine and proximal femur every 6 months.Safety of the drug was monitored by measuring blood and urine calcium frequently.

The study group was post menopausal women.

Inclusion criteria:

• postmenopausal women, age 60-78 years
• normal general laboratory tests
• serum calcium >10.6 mg/dl (2.65 mmol/L ) or >0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests,
• 24-hour urine calcium < 300mg (7.5mmol) on two baseline tests,
• Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2

Exclusion criteria :

• no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis
• severe chronic illness, chronic renal failure ( serum creatinine >1.4mg/dl ,chronic heart failure,
• any terminal illness
• any history of cancer (except skin cancer) within the last 10 years,
• uncontrolled diabetes with significant proteinuria or fasting blood sugar > 140mg/dl
• alcoholism
• prolonged hospitalization , extended immobilizations or arthritis that prevents normal physical activity, hemiplegia, previous hip fracture
• no previous treatment with medication known to affect bone and calcium metabolism within the last year; chronic corticosteroid therapy > 10mg/day thiazides, taking long term bisphosphonates or had them for more than 3 months in the past year, parathyroid hormone or derivatives in the last year, estrogen therapy within the last 6 months, anticonvulsants such as phenytoin ,high dose phenobarbital
• BMI > 45kg/m2